Method and system for controlled infusion of therapeutic substances

ABSTRACT

Programmable infusion systems and method for controlled infusion of diagnostic or therapeutic substances (e.g., drugs, biologics, fluids, cell preparations, etc.) into the bodies of human or animal subjects.

FIELD OF THE INVENTION

The present invention relates generally to medical devices and methodsand more particularly to programmable infusion pump systems and theiruses in the treatment of medical disorders.

BACKGROUND OF THE INVENTION

Various types of programmable infusion pumps have been used to delivercontrolled infusions (e.g., intravenous infusions, epidural infusions,subcutaneous infusions, enteral infusions, etc.) to patients in hospitaland out-of-hospital settings. Programmable infusion pumps are used toadminister a wide range of drugs, biological therapies and othersubstances, including but not limited to cancer chemotherapy, analgesicmedications, Immune Globulin therapy, insulin, etc. Programmableinfusion pumps typically include safety features that control or limitthe rate of infusion and the amount of solution delivered to thepatient, thereby preventing inadvertent overdosing, underdosing and/orinfusion rate-related side effects. Some programmable infusion pumpsalso include other safety features such as automated air-in-linedetectors, etc. These types of safety features are not typicallyavailable with non-programmable pumps or hanging intravenous drips.

The infusion pump systems of the prior art have included varying degreesof programmability and/or automation. Examples of infusion pump systemsthat are programmable and/or have some degree of automation include, butare not limited to, those described in U.S. Pat. No. 4,670,007 (Wheeldonet al.); U.S. Pat. No. 4,978,335 (Arthur, III); U.S. Pat. No. 4,976,151(Morshita); U.S. Pat. No. 4,856,339 (Williams); U.S. Pat. No. 5,256,157(Samiotes, et al.); U.S. Pat. No. 5,756,327 (Sasanfar, et al.); U.S.Pat. No. 5,683,367 (Jordan, et al.); U.S. Pat. No. 6,269,340 (Ford, etal.); U.S. Pat. No. 6,854,620 (Ramey) and U.S. Pat. No. 6,659,980(Moberg, et al.) as well as United States Patent Application PublicationNos. 2004/0019607 (Moubayed et al.) and 2004/0172283 (Vanderveen etal.).

One particular use for programmable infusion pump technology is in theadministration of Immune Globulin (Ig) therapy. Immune Globulin may beinfused intravenously (e.g., Intravenous Immune Globulin (IVIG) Therapy)or subcutaneously (e.g. Subcutaneous Immune Globulin (SQIG) therapy).Immune Globulin therapies have been used to treat primaryimmunodeficiencies (e.g., congenital agammaglobulinemia,hypogammaglobulinemia, common variable immunodeficiency, X-linkedimmunodeficiency with hyperimmunoglobulin M, severe combinedimmunodeficiency (SCID) and Wiskott-Aldrich syndrome). Also, IVIGtherapy may be used in the treatment of Kawasaki Syndrome, B-CellChronic Lymphocytic Leukemia, Idiopathic Thrombocytopenic purpura (ITP),acute graft-versus-host disease associated interstitial pneumonia(infectious or idiopathic) after bone marrow transplantation (BMT),human immunodeficiency virus (HIV), as a treatment for AcuteGuillain-Barré Syndrome, refractory dermatomyositis,hperimmunoglobulinemia E syndrome, Lambert-Eaton Myasthenic Syndrome,Relapsing-Remitting Multiple Sclerosis, Parvovirus B19 Infection andassociated anemia, Chronic Inflammatory Demyelinating Polyneuropathies,Multifocal Motor Neuropathy (MMN), infectious diseases,adrenoleukodystrophy, acquired Factor VII inhibitors, acutelymphoblastic leukemia, anemia, autoimmune hemolytic anemia, aplasticanemia, diamond Blackfan anemia, Aplasia, Pure Red Cell anemia, asthma,inflammatory chest disease, Behcet's syndrome, chronic fatigue syndrome,clostridium difficile toxin, congenital heart block, cystic fibrosis,intractable pediatric epilepsy, juvenile arthritis, myositis,polymyositis, multiple myeloma and immunoproliferative neoplasms, motorneuron syndromes, myasthenia gravis, myelopathy associated with HumanT-cell leukemia/lymphoma virus-I, nephrotic syndrome, membraneousneuropathy, paraproteinemic neuropathy, euthyroid opthalmopathy,recurrent otitis media, pemphigus vulgaris, pemphigus foliaceus,paraneoplastic pemphigus, progressive lumbosacral plexopathy,post-transfusion purpura, recurrent fetal loss, renal failure,rheumatoid arthritis, systemic lupus erythematosus and relatedcytopenia, nephritis, CNS involvement, vasculitis, pericarditis, orpleural effusion, thrombotic thrombocytopenic purpura, nonimmunethrombocytopenia, neonatal alloimmune thrombocytopenia (pre- andpostnatal), septic thrombocytopenia, quinine induced thrombocytopenia,transfusion reactions, uveitis, systemic vasculitic syndromes, acquiredVon Willebrand's syndrome and others.

Immune Globulin infusions must be carefully prescribed and administered.IVIG infusions are often administered by an infusion protocol wherebythe rate of infusion is increased in a step-wise fashion. Prior to eachincrease in the infusion rate (e.g., each “step up”), the patient ismonitored for signs of adverse reaction. If no adverse reaction is notedand the patient appears to be tolerating the infusion, then the infusionrate is increased (e.g., stepped up). The types of adverse reaction thatmay occur as a result of IVIG infusion include migraine headache,flushing, nausea, vomiting, chills and others. There is also a risk ofmore serious, sometimes life-threatening reactions, for example, risk ofthrombus formation. Particular care must be given to patients havingcertain health issues such as a history of stroke, heart attack, bloodvessel disease, IgA or IgG deficiencies or blood clots.

With the heightened emphasis on cost-effectiveness and cost-containmentin health care, home infusion therapy is becoming increasinglycommonplace. Home infusion therapy generally involves the administrationof medications, for example, Immune Globulin infusions usingintravenous, or subcutaneous routes, in the patient's home rather thanin a physician's office or hospital. Infusion therapies in the home aretypically administered by a home health care worker having some trainingin the operation of infusion equipment and the administration ofbiologic therapies, but in some cases may be administered by a patienthimself. Thus, it can be appreciated that there is a need for systemsand methods that incorporate careful monitoring of patient reactions andvital signs during administration of infusion therapies, for example,IVIG.

Other particular uses for programmable infusion pumps include, but arenot limited to, the administration of analgesics, anesthetics, cancerchemotherapy, antibiotics, gene therapy agents, anti-venoms and otherdrugs or substances that require carefully controlled and/or monitoredinfusion to avoid harmful reactions, overdosing, allergic responses,anaphylactic responses, other idiosyncratic responses, etc.

There remains a need in the art for the development of new programmableinfusion systems that provide for improved infusion control andsymptom/side effect monitoring during and/or after the infusion.

SUMMARY OF THE INVENTION

In accordance with the present invention there is provided a system foradministering a substance to a human or non-human animal subject. Ingeneral, this system comprises a) a pump, b) a substance administrationconduit for delivering the substance to the subject's body, c) a subjectdatabase containing information on at least one human or non-humananimal subject and d) a controller that is in communication with thepump and issues control signals to the pump, such controller beingadapted to access information on the subject from the subjectinformation database. The subject database may contain various types ofinformation that is specific to each human or animal subject, includingfor example; name, address, age, body weight, medical history, a list ofother medications received, allergies, reaction(s) to previousinfusions, preferred vascular access site(s), prescriptions forsubstances to be infused, etc. In some embodiments, the subject databasemay include information obtained from personal responses provided by thesubject regarding his/her reaction to the current or prior infusions ofthe substance. In such embodiments, the system may include apparatus forposing queries to the subject and for receiving/storing the subject'sresponses to such queries. Alternatively or additionally, in someembodiments, the subject database may include information obtained bymonitoring the subject's bodily or physiologic responses to the currentor prior infusions of the substance. In such embodiments, the system mayinclude apparatus (e.g., a feedback loop) for monitoring bodily orphysiologic variable(s) that are potentially indicative of the subject'sbodily and or physiologic responses to an infusion (e.g., heart rate,blood pressure, body temperature, respiratory rate, oxygen saturation,galvanic skin response, airway resistance, etc.) and forreceiving/storing information relating to changes in those monitoredvariables.

Further in accordance with the invention, the above-summarized systemmay optionally include a substance database that contains information onat least one substance that the system may administer to subject(s). Inembodiments that include the substance database, the controller may befurther adapted to access substance information from the substancedatabase. The substance database may contain one or more pre-defined,substance-specific infusion protocols that may be used foradministration of a particular substance and/or other types ofinformation on specific therapeutic substances (e.g., dosageinformation, recommended infusion rate information, substance-substanceinteractions, known side effects or adverse reactions, etc.) on varioussubstance(s) (e.g., drugs, biologics, etc.). In some embodiments, thesubstance database may group substance information by category (e.g.,therapeutic categories, drug categories, etc.). Optionally, the systemmay incorporate a user interface (e.g., a keyboard, touch screen, voicerecognition or other data input apparatus) or may have a hard wired orwireless connection to a separate data input apparatus or data storagedevice (e.g., a wired or wireless network, a personal computer, personaldigital assistant, laptop computer, disc drive, USB flash drive, etc.)whereby substance-specific infusion protocols or other substanceinformation may be transferred (e.g., loaded) to and stored by thesubstance database. In this regard, a user may create one or moreprescribed infusion protocols for a particular substance and may thenmanually input or download those custom made, substance-specificinfusion protocols to be stored in the substance database in connectionwith the particular substance to which they pertain.

Still further in accordance with the invention, the above-summarizedsystem may optionally include an infusion database containing infusioninformation (e.g., generic or pre-defined infusion parameters orprotocols that are not specific to a particular substance) and thecontroller may be further adapted to access infusion parameterinformation from the infusion database. The infusion database maycontain various types of infusion information including, for example, avariety of pre-set infusion protocols, specific infusion parameters(e.g., rate(s), volume(s) and time(s). The term “infusion protocol” asused herein refers to a series of pump control instructions that controlsome or all of the following: rate(s) at which the pump will infuse thesubstance, when change(s) in infusion rate will occur, the volume ofinfusate to be infused, the duration of infusion, the infusion profile,the infusion schedule, etc. In some cases the infusion protocol may be astep-wise protocol wherein the substance is infused at a first rate fora first infusion period (e.g., a period of time or until a predeterminedamount of the substance has been delivered) then to change to a secondflow rate for a second infusion period. This may repeat for one or moresubsequent infusion periods (e.g., the total number (n) of infusionperiods may be 2 or more). In other cases the infusion protocol mayprovide for continual increase and/or decrease of the infusion rate(e.g., a continuous ramp up and/or down) rather than changing infusionrates at discrete periods as in the step-wise protocol.

These and other aspects and advantages of the present invention areapparent in the following detailed description and claims, particularlywhen considered in conjunction with the following drawings in which likeparts are identified by like reference numerals.

BRIEF DESCRIPTION OF THE DRAWINGS

FIG. 1 is a general diagram of an infusion system of the presentinvention.

FIG. 2 is a diagram of one embodiment of an infusion system of thepresent invention useable to administer IVIG therapy and other biologictherapies.

FIG. 3 is a diagram of various databases and records that may beincorporated into or accessed by an infusion system of the presentinvention.

FIG. 4 is a flow diagram of a method for creating and storing a newinfusion protocol to be used by an infusion system of the presentinvention.

FIG. 5 is a flow diagram showing alternate methods that may be used forselecting and optionally modifying an infusion protocol to be used by aninfusion system of the present invention.

FIG. 6 is a flow diagram showing an embodiment of of the presentinvention wherein an infusion system is used to administer an infusionto a patient while monitoring the patient's response to such infusion.

FIG. 7 shows an example of a home menu that may be displayed by aninfusion system of the present invention.

FIG. 8 shows an example of a standby menu that may be displayed by aninfusion system of the present invention.

FIG. 9 shows an example of an Rx summary menu that may be displayed byan infusion system of the present invention.

FIG. 10 shows an example of a select Rx menu that may be displayed by aninfusion system of the present invention.

FIG. 11 is a graph of Infusion Rate v. Time, showing an example of anIVIG infusion profile that may be delivered using an infusion system ofthe present invention.

DETAILED DESCRIPTION OF THE INVENTION

The following detailed description and the accompanying drawings areintended to describe some, but not necessarily all, examples orembodiments of the invention. The contents of this detailed descriptionand the accompanying drawings are not necessarily all-inclusive and donot limit the scope of the invention in any way.

FIG. 1 shows the programmable infusion system 10 of the presentinvention. In this example, the system 10 generally comprises aninfusion pump 12, an infusate-containing vessel 16, an infusion conduit18, a controller 14 for controlling the pump, a data storage medium 20accessible by the controller 14. The data storage medium 20 is useablefor storage of, and access to, one or more databases such as a substanceprotocol database 22 and/or a subject protocol database 24 and/or andinfusion protocol database 26 and/or a substance reference library 40and/or system configuration parameters 41 and/or a history file 43. Inembodiments that include a substance reference library 40, suchsubstance reference library 40 may be a separate database or may beincorporated as part of the substance protocol database 22.

In addition, system 10 may include one or more interfacing device(s) 28(e.g., a personal computer 28 a, USB flash memory drive 28 a′, personaldigital assistant (PDA) 28 b, barcode reader 28 c, and/or telephonymodem) accessible to controller 14. Further, a user interface device 30(e.g., touch screen, mouse, keyboard, voice recognition system, or otherdata input apparatus) may be connected to the controller 14 and may beused to control and program the system.

The components of the system, such as the controller 14, interfacedevices 28, data storage medium 20 and user interface device 30, may beincorporated as subsystems within pump 12, or may exist as separatesubsystem(s) external to the pump 12 or may be integrated along with thepump 12 in a common housing, console, cart, etc. Alternative embodimentsinclude all possible combinations wherein one or more subsystem(s)is/are incorporated within the pump 12 or may be integrated along withthe pump 12 in a common housing, console, cart, etc while one or moreother subsystem(s) are external to the pump 12. For example, controller14 and data storage medium 20 could be incorporated into the pump 12 ormay be integrated along with the pump 12 in a common housing, console,cart, etc while user interface device 30 and interface devices 28 couldbe external to the pump 12 or the housing, console, cart of other bodyor enclosure in which the pump is located.

It will be appreciated that the pump 12 may be any suitable type ofpump. In some embodiments a peristaltic pump may be employed. Suchperistaltic pump may comprise any suitable type of peristaltic pump,including but not limited to traditional peristaltic pumps, curvilinearperistaltic pumps such as those described in U.S. Pat. Nos. 6,371,732,6,164,921 and/or 5,791,881, a linear peristaltic pump as described inU.S. Pat. No. 5,924,852 or a rotary axial peristaltic pump such as thatdescribed in copending U.S. patent application Ser. No. 11/212,931, theentire disclosures of such patents and patent application beingexpressly incorporated herein by reference. Basically, a “rotary axialperistaltic pump” comprises a platen having a platen surface, a tubepositioned adjacent to the platen surface, a cam that rotates about arotational axis, such cam having a cam surface that is spaced apart fromthe platen surface and a plurality of fingers, each finger having alongitudinal axis that is substantially parallel to the rotational axisof the cam. The fingers engage the cam surface such that, as the camrotates about the rotational axis, the fingers will move axially backand forth, sequentially compressing the tube against the platen surface,thereby causing peristaltic movement of fluid through the tube.

The system 10 may be in communication (via wired or wireless connection)with one or more external interface devices 28. Controller 14 may beprogrammed to transfer all or part of any database (e.g., all or part ofthe substance protocol database 22, subject protocol database 24,therapy-type protocol database 26, substance reference library database40, system configuration database 41 and/or history database 43 to orfrom external interface device(s) 28. For example, as illustrated inFIG. 3, the user may create one or more substance protocols 200, subjectprotocols 204, or therapy-type infusion protocols 36 on externalinterface devices 28 and subsequently command the system 10, via theuser interface device 30, to copy, or download, the protocols to theirrespective databases on in the data storage medium 20. Likewise, thehistory file 43 may be copied, or uploaded, from the data storage mediumdevice 20 to external interface devices 28 as commanded by the user

In one embodiment, after a new substance protocol has been downloaded orcreated on the system 10 and if a substance reference record 42 existsin the substance reference library 40 for the substance incorporated inthe new substance protocol, the program operating in the controller 14may check each parameter of the new substance protocol against parameterlimits found in the substance reference record 42 and against the systemconfiguration parameters 41. If any parameter of the new substanceprotocol violates the limits of the substance reference record 42 or thesystem configuration parameters 41, the controller 14 may then providean error signal and/or disallow storage of the new substance protocol tothe substance protocol database 22 and prevent execution of the newsubstance protocol. In some embodiments, the program operating in thecontroller may allow the violation to be overridden such that a newsubstance protocol, with an out-of-limit parameter, may be stored and/orexecuted. Permission to override a limit violation may be controlled byproper authorization techniques (e.g., by entry of a supervisingphysician's code or PIN).

In embodiments that incorporate a subject protocol database 24, subjectprotocol records may contain subject information 202 containing variousinformation that is specific to a human or animal subject, including forexample the subject's name, address, age, body weight, gender, medicalhistory, a list of other medications received, allergies, reaction(s) toprevious infusions, preferred vascular access site(s), prescriptions forsubstance to be infused, etc. Subject information 202 may be input intothe subject protocol database 24 through the user interface 30 ordownloaded from another source such as interface devices 28 (e.g.,personal computer 28 a, USB flash drive device 28 a′, PDA 28 b, barcodereader 28 c where a barcode containing such information is read, orconnected modem 28 d, etc.)

In one embodiment, a barcode label attached to the infusate vessel 16contains information regarding the make up and/or substance of theinfusate contained in the vessel 16, and/or information about thesubject to receive the administration of the infusate, and/or thedefinition of the infusion protocol for the administration of theinfusate. By use of a barcode reader 28 c, the barcode label may be readand its information transferred to controller 14 where the programrunning on the controller 14 may validate the barcode label informationagainst a substance reference record 42, if a correlating substancereference record exists in the substance reference library 40, andagainst the system configuration parameters 41. If the infusion protocolparameters within barcode label information violate one or manyparameter limits found in an available substance reference record 42 orthe system configuration parameters 41, the controller 14 may preventthe barcode information from being stored or executed; however, suchviolation may be overridden with proper authorization. Further, barcodesubject data that is inconsistent with any available subject information48 found in the subject protocol database 24 may prohibit the storage orexecution of the infusion protocol; however, such prohibition may beoverridden when properly authorized.

In embodiments of the system 10 that incorporate the optional subjectquery/response device 30 (also known as the user interface device) suchquery/response device 30 may be used to pose queries to the subject atcertain times (e.g., specific times before, during or after a dose ofthe infusion) and to input to the controller 14 the subject's responsesto those queries.

For example, the subject query/response device 30 may comprise aterminal that has a monitor or screen on which specific questions aredisplayed in written form and/or a speaker that poses audible queries tothe subject in spoken form. Further, the input apparatus of the subjectquery/response device 30 may comprise a touch screen, mouse, keypad,switch(s), joystick, encoder wheel, or other apparatus by which thesubject may input their response to presented queries. The controller 14may be in communication with the query/response device 30 and programmedto present the queries to the subject at the desired points in time andto receive the subject's responses to the queries and to evaluate andstore the responses. As part of the evaluation process, the controller14 may be programmed to compare the subject's query responses to areference library containing acceptable and/or unacceptable responses.If the subject's response to a query is determined to be unacceptable,the controller 14 may be programmed to provide an alarm or notice to theuser and/or halt the infusion and/or alter the infusion's execution(e.g., reduce the infusion rate or stop the infusion.) For example,during the administration of an infusion of a Drug X, the controller mayquery the subject at different points in time as to whether the subjectis experiencing adverse reaction symptoms that are known to occur insome individuals who receive Drug X (e.g., the query might be: Are youcurrently experiencing hives or itchy skin?, Are you currentlyexperiencing wheezing or shortness of breath?, Are you currentlyexperiencing blurred vision?, etc.) The subject then answers each queryusing the input apparatus of the subject query/response device 30. Thecontroller 14 then compares the subject's query responses to a referencedatabase of acceptable and/or unacceptable responses and determines ifthe subject's query responses are indicative of an adverse reaction. Ifthe subject's query responses are determined to be indicative of anadverse reaction, the controller 14 may then effect remedial measure(s)in accordance with its programming. For example, if a subject's responseindicates that he or she has begun to suffer a headache, the controller14 may respond by changing the control signals to the pump 12 to reducethe infusion rate by a predetermined amount (e.g., 50%) and may thenre-query the subject at some later time, or at periodic time intervals(e.g., 5 minutes) to determine if the headache is continuing. If thesubject's query response indicates that he or she is no longerexperiencing the headache, the controller 14 may then signal the pump 12to continue the infusion in accordance with the originally selectedprotocol or some reduced rate protocol in accordance with thecontrollers programming. On the other hand, if upon re-query the subjectresponds that he or she is continuing to experience the headache, thecontroller 14 my signal the pump to further reduce the rate of infusionor to halt the infusion and/or alert the operator in accordance with themanner the controller is programmed.

Alternatively or additionally, in some embodiments, the system mayincorporate sensor(s) 32 (e.g., vital sign monitors) for sensing certainbodily or physiologic variables and communicating those sensed variable(or indications of changes in sensed variables) to the controller 14.The bodily or physiologic variables monitored by the sensor(s) 32 mayinclude bodily and/or physiologic variable that change when a subject isexperiencing an adverse reaction to an infusion (e.g., heart rate, bloodpressure, body temperature, respiratory rate, oxygen saturation, carbonmonoxide saturation, galvanic skin response, airway restriction, etc.)The controller 14 may be programmed to issue special or modified controlsignals to the pump 12 (e.g., to slow the infusion rate or halt theinfusion) and/or to issue an alarm signal to the operator in the eventthat the controller 14 receives a signal from a sensor 32 indicative ofan adverse reaction or other untoward effect of the infusion. Also inembodiments of the system 10 that incorporate the optional subjectquery/response device 30 as well as the optional sensor(s) 32, thecontroller 14 may be programmed to pose specific queries to the subjectin order to confirm possible indications of adverse reactions detectedby the sensor(s) 32. Consider for example, hypothetical Drug Z, whichwhen infused too rapidly is known to cause an adverse reactioncharacterized by an increase in heart rate and nausea. In a case whereDrug Z is being infused too rapidly for the subject, the sensor(s) maycommunicate to the controller the subject's heart rate in a continuousfashion. The controller can then detect an increase of heart rate andcause the subject query/response device 30 to ask the subject whether heor she is experiencing nausea. If the subject responds in the negative,the controller 14 may allow the pump 12 to continue the infusion inaccordance with the original infusion protocol while continuing tomonitor for further changes in heart rate and/or periodically queryingthe subject for the occurrence of nausea. On the other hand, if thesubject responds that he or she is experiencing nausea, the controller14 may signal the pump 12 to modify the infusion protocol (e.g.,decrease the rate of infusion and/or forego further increases in therate of infusion) or to halt the infusion and/or to provide an alarm tothe operator, in accordance with the manner in which the controller isprogrammed.

In embodiments of the system 10 that incorporate an infusion protocoldatabase 26, such infusion protocol database 26 may contain pre-defined,non-specific infusion protocols or preset infusion parameters which theuser may select for use without regard to the substance to be infused orthe subject to receive the infusion. When a non-specific infusionprotocol has been selected from the infusion protocol database 26, orprogrammed via the user interface device 30, the controller 14 may checkthe parameters of the non-specific infusion protocol against the limitscontained in the system configuration parameters 41 by the controller 14to determine that all parameters are within perating limits. If anyparameter of the non-specific infusion protocol violates he systemconfiguration parameters 41, the controller 14 may then provide an errorsignal and disallow execution of the non-specific infusion protocol;however, such violation may be overridden with proper authorization.

Further, in embodiments that include a substance reference library 40,the operator may, by use of the user interface device 30, choose toassociate the non-specific infusion protocol to a particular substancereference record 42 found in the substance reference library 40. Oncethe association has been made, the controller 14 may check theparameters of the non-specific infusion protocol against the limitsfound in the substance reference record 42. If the parameters of thenon-specific infusion protocol violate the parameters of the substancereference record 42, the controller 14 may then provide an error signaland prevent execution of the non-specific infusion protocol; however,such violation may be overridden with proper authorization. Further,with proper authorization, the operator may modify the non-specificinfusion protocol so that none of its parameters are in violation of theselected substance reference record 42.

Lastly, in embodiments that include a subject protocol database 24, theoperator may, by use of the user interface device 30, choose toassociate the non-specific infusion protocol to a particular subjectprotocol record 48 found in the subject protocol database 24. Once theassociation has been made, the controller 14 may store the non-specificinfusion protocol as a subject protocol record 48 in the subjectprotocol database 24. In addition, if the non-specific infusion protocolhad previously been associated with a substance reference record 42, theadditional association with a subject protocol record 48, therebyidentifying a subject, may cause the parameters of the non-specificinfusion protocol to be checked against the substance reference record42 limits that are subject specific. For example, where a non-specificinfusion protocol has been associated with a substance reference record(e.g., Drug X which contains a limitation that the total amount infusedshall not exceed 10 mg per 100 lbs of subject weight) and thenon-specific infusion protocol is later associated with a subjectprotocol record (e.g., for Mr. Jones which includes information aboutMr. Jones' weight) then the controller 14 may determine if the substancereference record limitation for this specific subject is in violationgiven the non-specific infusion protocol parameter regarding totalamount of substance to be infused. Where the controller determines thata violation exists, the controller 14 may then provide an error signaland prevent execution of the non-specific infusion protocol; however,such violation may be overridden with proper authorization. Further,with proper authorization, the operator may modify the non-specificinfusion protocol so that none of its parameters are in violation.

Set forth below is a detailed example of an embodiment of the presentinvention.

EXAMPLE Smart Immune Globulin (SIG) Infusion System and Method

Referring to FIG. 2, the SIG infusion system of this example includes apump 10 a, which pump includes a controller, motor and electronics tooperate the pump, user interface device (e.g., liquid crystal displayand a touch screen overlaid on the LCD), various operator keys, a soundproducing audio subsystem, a microphone subsystem, a compact flashconnector into which a IEEE 802.11 (WiFi) wireless interface adaptor orBluetooth adaptor can be mounted, a Universal Serial Bus (USB) hostinterface connector, a USB client interface connector, a IEEE 802.3ethernet connector, and a EIA RS-232 serial interface connector. Thepump 10 a may include one or more sensor(s) operating on the conduit 18for detecting occlusions of the conduit 18 and/or air bubbles within theconduit 18 as may occur when the infusate bag or vessel 16 becomesempty, inadvertently disconnected or air leaks into the conduit 18 orvessel 16. The SIG infusion system of this example also incorporatesseveral interface devices which communicate directly with the controller14. These interface devices include: a personal computer 28 a, aremovable USB flash driver 28 a′, a personal digital assistant 28 b, abarcode reader 28 c, a first telephony modem 28 d and a second telephonymodem 28 e for providing connectivity to various computer networks,personal computers, vital signs monitoring equipment, and otherperipheral devices. Personal computer 28 a can be connected directly tothe controller 14 through interfaces of EIA RS232, USB client, IEEE802.3 Ethernet, or IEEE 802.11b wireless interface.

Through these interfaces the interface devices (28 a, 28 a′, 28 b, 28 c,28 d, and 28 e) may communicate with the controller 14 for the purposeof sending and retrieving files or records to/from the substanceprotocol databases 22, the subject protocol database 24, the infusionprotocol database 26, and the substance reference library 40 (if storedseparately from the substance protocol databases 22). In addition, thepersonal computer 28 a can monitor the activities of the SIG infusionsystem 10 a when connected. Alternatively or additionally, a personaldigital assistant (PDA) 28 b can be used to communicate with the SIGinfusion system via a hard wired connection such as EIA RS232, USB,and/or by a wireless interface such as an IEEE 802.11b wirelessinterface and perform many of the same functions as the personalcomputer.

In some embodiments of the invention, the personal computer 28 a and theSIG infusion system 10 a may both be equipped with ports, such as USBports, so that a transfer device such as a USB flash drive device 28 a′can be used as a medium for the transfer of files or data between thepersonal computer 28 a and the SIG infusion system 10 a. For example, aninfusion protocol may be created on the personal computer 28 a, thencopied to the USB flash drive 28 a′ and, thereafter, the USB flash drive28 a′ may be transported to and inserted in the corresponding USB portof the SIG infusion system 10 a such that the files or data may be readdirectly by the controller 14 or transferred to the controllers memoryfrom the USB flash drive 28 a′ and stored in the infusion protocoldatabase 26.

An optional barcode reader 28 c (e.g., DS6608, Symbol Technologies,Holtsville, N.Y. or LG2, Opticon, Inc., Orangeburg, N.Y.) can interfaceto the SIG infusion system by means of EIA RS232, USB, or IEEE 802.11bwireless interface for the purpose of reading and communicating barcodeinformation from barcode symbols located, for example, on subject's IDbracelet, drug reservoir, and/or operator's ID badge. Further, thebarcode reader 28 c can be used to program the SIG infusion system byreading a protocol, subject information and/or other data encoded on abarcode symbol affixed to the bag or other vessel 16 containing anImmune Globulin preparation to be infused.

FIG. 2 also shows the connecting of various sensors (also known as vitalsign monitors) 32 a, 32 b, 32 c to the controller 14 to monitor certainof the subject's vital signs. In particular, in this example, a firstsensor 32 a such as a pulse oximeter device (e.g., Radical, MasimoCorporation, Irvine, Calif. or OxiMax® N-595, Nellcor, Pleasanton,Calif.) is used to monitor pulse rate and oxygen saturation, a secondsensor 32 b such as a blood pressure monitor (e.g., UA-767PC, A&D Co.,Ltd., Saitama, Japan or HEM-711AC, Omron Corporation, Kyoto, Japan) isused to monitor blood pressure and a third sensor 32 c such as a bodytemperature monitoring device (e.g., Spot Vital Signs, Welch Allyn,Beaverton, Oregon or DataTherm, Geratherm Medical AG, Geschwenda,Germany) is used to monitor the subject's body temperature. Thesesensors 32 a, 32 b, 32 c are in communication with the controller 14 byway of a wired or wireless connections, such as an EIA RS232, USB, orIEEE 802.11b wireless interface. Pulse rate and oxygen saturation sensor32 a provides an automated acquisition means of obtaining subject pulserate and oxygen saturation level. Blood pressure sensor 32 b provides anautomated means of obtaining the current diastolic and systolic bloodpressure of the subject. Temperature sensor 32 c provides an automatedmeans of obtaining the subject's temperature. These vital signs sensors32 a, 32 b, 32 c provide feedback to the SIG infusion system 10 a duringthe infusion procedure and the controller 14 is programmed to analyzesuch feedback for signs indicating that the subject is having (or isabout to have) an adverse reaction to the infusion. If the SIG infusionsystem 10 a determines that the subject is having an adverse reactionbased on the information acquired from the monitoring devices 32 a, 32b, 32 c, the SIG infusion system 10 a can stop the infusion and notifythe operator of the subject condition, thereby averting potential injuryto the subject. Alternatively, the controller 14 may be programmed tomake adjustments in the infusion protocol (e.g., decrease the rate ofinfusion or stop the infusion) in response to certain monitored changesin certain vital signs that may be a prodrome or early indication of anadverse reaction, thereby avoiding occurrence of a clinicallysignificant or full blown adverse reaction.

Also, as shown in FIG. 2, in some embodiments a first telephony audiomodem 28 d may be connected to the SIG infusion system 10 a and a secondtelephony modem 28 e connected to a remote monitoring and control system29 such as a personal computer. Modems 28 d, 28 e, connected together bywired or wireless telephony, may provide peer-to-peer connectivity meansthus allowing a remote monitoring and control system 29 to interact withthe SIG infusion system 10 a directly. A remote monitoring and controlsystem 29 may also communicate with the SIG infusion system 10 a in apeer-to-peer connection via IEEE 802.11 or Bluetooth wireless interface.Lastly, the remote monitoring and control system 29 can be connected toa in-house network which includes IEEE 802.11 wireless access pointsdevices through which the SIG infusion system, via IEEE 802.11 wirelessinterface, can communicate with the remote monitoring and control system29, such as in a hospital environment.

Databases and Records

FIG. 3 illustrates an embodiment of a set of databases, folders, files,and/or records that are created, maintained, and accessed in the processof programming, selecting, and executing protocols for use by the SIGinfusion system 10 a. In this example, non-specific infusion protocols(comprising infusion protocol, infusion frequency, etc.), substanceprotocols (comprising substance name, manufacturer (if specified),diluent/solvent to be used, substance concentration in infusate,specific instructions of infusate preparation/reconstitution/dilution,etc.) and subject protocols (comprising specifications for subject'sage, weight, date of birth, infusion protocol, etc.) are created by theoperator using the SIG infusion system 10 a or remotely on a personalcomputer 28 a using an Infusion Configuration Program (ICP). Protocolscreated using an ICP may subsequently be transferred to the appropriatedatabases of the SIG infusion system 10 a. A substance protocol mayinclude information (e.g., substance name and concentration) relating toa specific therapeutic agent and optionally a link to a substancereference record 42 in a substance reference library 40 for the purposeof confirming that the substance protocol is within allowableparameters.

Infusion Protocol Database

In the example shown in FIG. 3, the infusion protocol database 26provides storage for infusion protocols (e.g., non-specific infusionprotocols and other information included in a particular infusionprotocol). In this embodiment, infusion protocols may be categorized ororganized in three therapy categories: IVIG, SQIG and CONT. The CONTtherapy category is a continuous infusion mode wherein a continuousinfusion is administered by a desired route of administration (e.g.,intravenous, subcutaneous, epidural, etc.) Each therapy category canhave any number of infusion protocols in it. In one embodiment, thetherapy grouping is accomplished by use of file folders 34 maintained ona computer 28 a with a flash disk drive or other suitable storagedevice. On the flash disk drive three file folders 34 are created, onefor each therapy type. Non-specific infusion protocols are created andstored in file folders 34 according to therapy type.

Substance Protocol Database

The substance protocol database 22 stores substance protocols that areintended to be used when infusing particular substances as describedgenerally hereabove. In this example, the substance database 23 isdivided into three files or categories, namely IVIG, SQIG and CONT, in amanner similar to the infusion database. Each therapy category can haveany number substance protocols for a verity of substance's (e.g.,various different Immune Globulin preparations). In one embodiment, thetherapy grouping is accomplished by use of file folders 38 maintained ona computer system with a flash disk drive or other suitable storagedevice. On the flash disk drive three file folders 38 are created, onefor each therapy type. As substance protocols are created or downloaded,they are stored in the flash disk drive folder according to theirtherapy type.

Substance protocols stored in the substance protocol database 22 defineinfusion parameters and the substance to be infused. The substance to beinfused may or may not exist as a substance reference record 42 in thesubstance reference library 46. If a substance reference record 42 forthe particular substance is found in the substance reference library 46(identified by substance name, concentration, and requiredadministration route) then the parameters of the substance protocol arecompared to corresponding program infusion limits found in the substancereference record 42. If a specific substance reference record 42 is notfound in the substance reference library 46, the operator may then inputthe substance name, concentration, and required administration route andhowever, no comparison of the inputted parameters of the substanceprotocol to program infusion limits from a substance reference record 42will be made nor will adverse reaction monitoring be performed. In thisexample, no subject data is included in the substance protocols storedin the substance protocol database 22.

It will be appreciated that adverse reaction feedback monitoring my beused even when no substance reference record 42 is in use. For example,the system may be programmed with absolute limits for monitoredparameters (e.g., heart rate, body temperature, etc.) and when one ormore of those absolute limits are exceeded, the controller 14 mayundertake remedial measures such as a decrease of infusion rate or stopthe infusion.

Subject Protocol Database

In this example, the subject protocol database 24 is used for storage ofsubject data and subject protocols for individual subjects to receiveImmune Globulin infusions (either IVIG or SQIG) from this SIG system 10a. In many applications, such as in-hospital and home infusionapplications, a single SIG infusion system 10 a may be used to treat anumber of different subjects and the subject protocol database 24 allowsthe SIG system 10 a to store and recall information on each of thosesubjects. Subject-specific infusion protocols or other subjectinformation may be organized and stored in separate folders 48 for eachsubject. The controller may be programmed to allow each subject folder48 to contain only one set of subject information and no more than oneof each type of therapeutic protocol (e.g., IVIG therapy protocol, SQIGtherapy protocol, and CONT therapy protocol.) Alternatively, thecontroller may be programmed to allow each subject folder 48 to containone set of subject information and multiple therapeutic protocols ofeach therapeutic types.

Substance Reference Library

The Substance Reference Library 46 provides storage for one or moresubstance reference records 42 or other substance information. In oneembodiment, each substance reference record 42 may identify by substancename, substance concentration, and required administration route. Asubstance reference record 42 may also contain program infusion limitsthat the controller 14 will use to determine if the substance protocolto be executed is safely within the substance reference record limits.The substance reference record 42 may include various absolute infusionlimits (e.g., absolute maximum infusion rate, absolute maximum volume tobe infused, absolute maximum duration, and absolute minimum duration.)In addition, the substance reference record 42 may include variableinfusion limits dependent on subject's weight, age and/or gender.Therefore, when a subject's weight, age, and gender are known, aparticular set of program infusion limits, more conservative than theabsolute limits, may be retrieved from the substance reference record 42for comparison to the infusion protocol parameters.

The substance reference record 42 also may contain a recommended totaldose amount per a course of treatment based on a particular disease thesubject may be suffering. When multiple protocols for the same substanceare administered to the same subject, the SIG infusion system 10 a maykeep a running total of the amount of the particular substance thesubject has received. If the running total of the amount of substanceexceeds the specified total dose amount per course of treatment, thenthe SIG infusion system 10 a may issue an alarm stopping the infusionand alerting the operator.

The substance reference record 42 may also include an adverse reactionsymptom list 46 which contains a predetermined list of symptoms, thecriteria for which the symptom is to be considered an adverse reaction,a classification of the adverse reaction, and additional textinformation to be presented to the operator via the user interfacedevice 30 in the event that the adverse reaction is detected.

An optional pre-infusion checklist can be added to a substance referencerecord 42 and the controller 14 may be programmed to cause thatpre-infusion checklist to be displayed to the operator before aninfusion is begun. The pre-infusion checklist may contain textualinstruction for the operator of the SIG infusion system 10 a who isabout to begin an infusion. Such instructions can remind the operator,for example, to make various vital signs checks of the subject prior torunning the infusion and/or to be sure the subject had beenpre-medicated.

FIG. 3 illustrates an embodiment that includes a substance referencelibrary configurator program 44 that is operable on a personal computer28 a and useable to create and maintain the substance reference library40. A substance reference library 40 may be created, and substancereference records 42 may be added, modified or deleted, using thesubstance reference library configurator program 44. In order to controlaccess and integrity of the substance reference library, the substancereference library configurator program 44 cannot be operated on the SIGinfusion system 10 a itself.

The adverse reaction symptom selection list 46 is a list of physiologicsymptoms that a subject may suffer during an infusion. In oneembodiment, this list 46 is a list of various symptoms a subject maysuffer during an infusion of IVIG. Such symptoms may include high or lowblood pressure, high or low body temperature, low oxygen saturationlevel, high or low pulse rate, headache, shortness of breath, nausea,vomiting, lightheadedness and others. This list 46 may be merelyrepresentative and not exhaustive. The adverse reaction symptomselection list 46 is accessible by the substance reference libraryconfigurator program 44 for use by the operator in creation of asubstance reference record 42.

The substance reference library 40 should be created and maintained byan authorized party of the institution responsible for the infusion. Inas much as the substance reference library 40 may be critical to thesafe infusion of IVIG and other substances, security of the substancereference library 40 may be important. In one embodiment, security ofthe substance reference library 40 may be accomplished by providingsubstance reference library configurator program 44 that properlyinterprets and modifies the contents of a substance reference library40. Further, the substance reference library 40 itself may include oneor several cyclic redundancy check (CRC) parameters which allows thesubstance reference library configurator program 44 to determine if thecontents of the substance reference library 40 had been changed sincethe CRC parameters were last calculated and stored. In addition,pharmacists or administration personnel may be required to log into thesubstance reference library configurator program 44 by providing theirusemame and password in order to operate the program. The authorizedparty may thereby create or modify substance reference records 42 bydefining absolute infusion limits, one or more sets of program infusionlimits based on weight, age, and gender of potential subjects, andmaximum substance amount to be infused for a course of treatment basedon the disease the subject may be suffering. The modified or newlycreated substance reference records 42 will then be applied to allsubstance infusion protocols 200 that reference the substance referencerecord 42. Sources of information needed to create or modify a substancereference record 42 are the substance manufacturers or as otherwiseknown in the medical infusion community.

In addition, the authorized party creating or modifying a substancereference record 42 may select appropriate symptoms from the adversereaction symptom selection list 46 that relate to the infusion of thespecific type of IVIG substance. For each selected adverse reactionsymptom, criteria for classifying the adverse reaction as mild, moderateor severe is provided by the authorized party. For adverse reactionsymptoms, mild, moderate, and severe, the authorized party may alsodefine a message to be displayed to the operator on the occurrence ofthe mild, moderate or severe adverse reaction symptom. Sources forcriteria constituting an adverse reaction are the substance manufactureror as otherwise known in the medical infusion community.

After all substance reference records 42 have been entered into thesubstance reference library 40, the substance reference library 40 issaved to the personal computer 28 a hard drive, or alternatively to anetwork server if the personal computer 28 a is connected to a network.By use of the substance reference library configurator program 44, theauthorized party may also perform maintenance functions on the substancereference library 40 such as renaming, erasing, copying, printing, ordeleting substance reference records 42. A modified substance referencerecord 42 can be saved as a new substance reference record 42 oroverwrite the original source substance reference record 42.

In order for a SIG infusion system 10 a to use the substance referencelibrary 40, the substance reference library 40 must be transferred tothe SIG infusion system 10 a by a communication means such as a wired orwireless interface device 28. Various wired interfaces are contemplatedin this invention for communication between a personal computer 28 a ornetwork server and the SIG infusion system 10 a such as EIA RS-232serial interface, IEEE 802.3 Ethernet, and Universal System Bus (USB).Alternatively, wireless communication means such as IEEE 802.11 WiFi orBluetooth technologies can be applied for the transfer of the substancereference library 40 to the SIG infusion system. Further, transfer of asubstance reference library 40 from the computer 28 a on which it hasbeen prepared to the controller 14 of the SIG infusion system 10 a, maybe accomplished by use of data medium device such as a USB flash drive28 a′. In such instances, the substance reference library 40 will becopied to a folder on the USB Flash Drive 28 a′. Then the USB FlashDrive 28 a′ is removed from the personal computer 28 a or network systemand inserted into a USB port of the SIG infusion system 10 a and, aftersatisfying security access requirements, the substance reference library40 is saved into the memory of the controller 14. Conversely, when it isdesired to update or modify a substance reference library 40 (or any ofthe databases 22, 24, 26 stored in the controller 14 memory) suchsubstance reference library 40 may be uploaded from the controller 14 tothe USB Flash Drive 28 a′ and then transferred to the computer 28 awhere the desired updating or changes may be made.

Menus

Home Menu

In this example, all operator interaction with the SIG infusion system10 begins at the “HOME” menu as shown in FIG. 7. When the SIG infusionsystem 10 a is first turned on, the home menu is displayed on the LCDdisplay. In addition, when no infusion is in progress, the SIG infusionsystem 10 a menus will permit the operator to select to go to the homemenu.

The HOME menu provides a varying list of selections based on theparticular state of the SIG infusion system. The possible selectionsare: CONTINUE Rx, REPEAT Rx, SELECT Rx, and PROGRAM NEW Rx.

Continue Rx

The CONTINUE Rx selection is available if an infusion was stopped beforeit was finished. If the operator chooses CONTINUE Rx, the operator ispresented the standby menu, shown in FIG. 8.

Repeat Rx

The REPEAT Rx selection is available if an infusion that had been inprogress was either stopped or completed. If an infusion that was inprogress was stopped before completion and an attempt to repeat theinfusion protocol is made, then the controller 14 of the SIG infusionsystem 10 a will alert the operator that proceeding will result incancellation of the previously interrupted infusion. If no infusion hadbeen in progress or if the operator acknowledges canceling of theinfusion that was in progress, the Rx SUMMARY form shown in FIG. 9 willappear. If the operator accepts the Rx SUMMARY form, the SIG infusionsystem 10 a will display the STANDBY menu, shown in FIG. 8, from whichthe operator can then run the infusion.

Standby Menu

The STANDBY menu is displayed when programming is complete, or acceptingan Rx SUMMARY form, or when the CONTINUE Rx button is pressed on theHOME menu, and when clearing an Alarm. From the STANDBY menu, theoperator can: a) run the infusion, b) prime the conduit, c)review/modify the infusion or d) set a delay start time for theinfusion.

Select Rx

The SELECT Rx selection is available if there is at least one infusionprotocol selectable from the database(s) 22 and/or 24 and/or 26 storedin the memory of the controller 14. If the infusion in progress had beenstopped and an attempt to select another infusion protocol is made, thenthe SIG infusion system alerts the operator that proceeding will cancelthe Rx that had been stopped. If no infusion had been in progress or theoperator acknowledges canceling of the Rx in progress, a SELECT Rx menu,shown in FIG. 10, is displayed allowing selection of a subject protocolfrom the subject protocol database, substance protocol form thesubstance protocol database, or an infusion protocol from the infusionprotocol database.

Program New Rx

The PROGRAM NEW Rx is always an available selection on the HOME menu. Ifthe infusion in progress had been stopped and an attempt to program newRx is made, then the SIG infusion system alerts the operator thatproceeding will cancel the Rx that had been stopped. If no Rx had beenin progress or the operator acknowledges canceling of the Rx inprogress, she will have the opportunity to create a new Rx as describedlater in this disclosure.

Initiate Rx

In the event the SIG infusion system was programmed with an Rx or an Rxselected from an Rx database and the SIG infusion system was turned off,the subsequent turn on of the SIG infusion system will present theoperator with the HOME menu; however, the INITIATE Rx selection willappear in place of the REPEAT Rx selection. When the operator selectsthe INITIATE Rx, the Rx SUMMARY form will be displayed. If the operatoraccepts the Rx SUMMARY form, the SIG infusion system 10 a will displaythe STANDBY menu, shown in FIG. 8, from which the operator can then runthe infusion.

Satisfy Security Requirements

When the operator selects REPEAT Rx, SELECT Rx, or INITIATE Rx, she maybe required to enter an access code on the SIG infusion system via touchscreen entry to satisfy security access. Alternatively, the operatormight be required to identify herself to the SIG infusion system programby use of a barcode reader, attached to the SIG infusion system, whichis used to read the operator's barcode information from her badge.

RxSUMMARY

Referring to FIG. 9, the Rx SUMMARY form provides a summary of theinfusion parameters which the operator may accept, modify, or cancel. Ifthe operator elects to modify the infusion parameters, the operator isthen presented with the infusion programming screen (of the therapeutictype) and makes the desired modifications. After making modificationsthe operator accepts the modification and the infusion is checkedagainst substance reference record 42 infusion limits if the Rx includesa reference to an existing substance reference record 42. The operatorcan then save the modified infusion as a new infusion protocol, ifapplicable, or overwrite the original infusion protocol.

Creating a New Infusion Protocol

Satisfy Security Requirements

FIG. 4 illustrates a method of creating an infusion protocol. The SIGinfusion system 10 a allows programming an infusion protocol after theoperator has satisfied the security requirements 50 of the SIG infusionsystem 10. In one embodiment, the operator may be required to enter anaccess code on the SIG infusion system 10 via touch screen.Alternatively, the operator might be required to identify herself to theSIG infusion system 10 a by use of a barcode reader 28 c to read theoperator's barcode information from a badge, identification card or thelike.

After the operator has satisfied the SIG infusion system's securityrequirements, the SIG infusion system 10 a program displays a selecttherapy menu 51 from which the operator selects the therapy type: IVIG,SQIG, or CONT. The operator then makes a selection of one of the therapytypes and proceeds to program the infusion parameters.

IVIG Infusion Parameters

In the case of IVIG therapy type, the operator inputs IVIG infusionparameters 52 for: volume to be infused, minimum infusion time, maximuminfusion time, maximum rate of infusion, base (initial) rate ofinfusion, rate increment, and step duration.

In the present invention, the infusion profile is calculated from theinfusion parameters prior to starting the infusion. One example of suchIVIG infusion profile is shown graphically in FIG. 11. The infusionprofile may consist of one or several steps wherein each step includesup to two segments. The first segment provides an approximate constantchange of rate or ramping segment (e.g., 12 milliliters/hour/second)from the terminal rate of the previous step (or zero in the case ofbeing the first step to be executed) to the terminal rate of the currentstep. This is represented on FIG. 11 by the initial up-sloped line atthe beginning of each of Steps 1, 2, 3 and 4. Once the terminal rate hasbeen achieved in any step, that step continues at the terminal rateuntil the volume to be infused for that step has been delivered, oruntil the step duration has elapsed. This is represented in FIG. 11 bythe flat line that follows the initial up-sloped line in each of Steps1, 2, 3 and 4. Where the change of rate is sufficiently high (e.g., 12milliliters/hour/second), the minimum step duration sufficiently long(e.g., 300 seconds) and the maximum rate of infusion is sufficientlylimited (e.g., 1000 milliliters/hour), each step will reach its terminalrate before the step has terminated (except potentially the last stepduring which it is possible that all the volume to be infused for theentire infusion has been delivered before the terminal rate of the laststep has been reached.) For example, where a single step is to startfrom an initial rate of 0 milliliters/hour and reach a maximum rate of1000 milliliters/hour and the constant change of rate is approximately12 milliliters/hour/sec (thereby maximizing the duration of ramping),the step will finish its first or ramping segment in 83.3 seconds whichis much less than the minimum step duration of 600 seconds; therefore, aterminal rate segment must follow the ramping segment.

The series of infusion profiles steps are computed by calculating thefirst step and then subsequent steps. The ramp segment of the fist stepstarts at a zero milliliters per hour rate and increases, at an almostconstant rate, until the rate reaches the base (initial) rate. Thecalculated volume delivered by the first step is calculated as the sumof the volume during the ramping segment and the terminal rate segment.The remaining volume is then calculated as the total volume to beinfused minus the volume of the first step. The number of possibleremaining steps can next be calculated by dividing the difference of themaximum rate of infusion and the base (initial) rate of infusion by therate increment, rounding the quotient up, and adding one to thequotient. The computations for each of the subsequent infusion steps isgenerally calculated by starting the ramp segment at the terminal rateachieved by the prior step and increasing the rate, by a constant changeof rate, until one full rate increment has been added to the terminalrate of the prior step; thereafter following with a terminal ratesegment maintaining the rate achieved at the end of the ramp segment.The calculated volume delivered for each step is subtracted from theremaining volume and if the remaining volume is reduced to zero or less,the step being calculate is considered the last step having a reducedvolume and execution time sufficient only to deliver the last of theremaining volume. If at any time the calculated rate of a step wouldexceed the maximum rate, the rate of that step is limited to the maximumrate. In addition, as the steps are calculate, their execution time issummed up and if their total execution time becomes equal to, or greaterthan, the maximum infusion time, that step under calculation will be thelast step and will terminate so that the infusion time will not exceedthe maximum infusion time. In the case where the rate of the last step(e.g., Step 4 in FIG. 11) has been limited by the maximum rate ofinfusion, the calculation for that step's duration will be extend untilall of the volume to be infused has been delivered or until the maximuminfusion time has been reached.

SQIG Infusion Parameters

In the case of SQIG therapy type, the operator inputs SQIG infusionparameters 53 for (or their value is calculated): volume to be infused,rate of infusion, and time of infusion. Time of infusion is calculatedwhen volume to be infused and rate of infusion are entered.

CONT Infusion Parameters

In the case of a continuous infusion therapy, the operator inputscontinuous infusion parameters 54 for (or their value is calculated):the units of measurement to be used (e.g., milliliters (ml), milligrams(mg), or micrograms (mcg)), the concentration of substance in theinfusate (if weight units such as milligrams or micrograms had beenselected), total volume of infusate (e.g., “bag volume”), the volume oramount of infusate to be infused, up ramp time, infusion rate (after upramp completed), total infusion time, and the keep vein open (KVO)infusion rate.

TPN Infusion Parameters

In the case of a total parental nutrition (TPN) infusion therapy, theoperator inputs parameters for (or their value is calculated): thevolume to be infused, up ramp time, infusion rate (after up rampcompleted), down ramp time, total infusion time, and the keep vein open(KVO) infusion rate. Total infusion time is calculated when volume to beinfused, rate of infusion, up ramp time, and down ramp time are entered.

Selecting a Substance Reference Record 42 to be Used with the InfusionProtocol

The operator may choose to associate 55 the infusion protocol with anexisting substance reference record 42, create a new substancespecification 56 by defining substance name, concentration, andadministration route, or not associate the Rx with any substanceinformation. If the operator creates a new substance specification, thenew specification will not be added to the substance reference library40 and will be used as textual information only by this infusion.

Associating Subject Data with the Non-Specific Infusion Protocol

The operator may choose to associate 57 previously defined subjectinformation from the subject protocol database 24 or to input newsubject information to be associated with a new subject. Subjectinformation may include subject's name, date of birth, weight, andgender.

Check Programmed Infusion Parameters Against Limits

After programming all infusion parameters and choosing whether toassociate the Rx with an existing substance reference record 42 andsubject data, the SIG infusion system will check the programmed infusionparameters against predefined absolute limits 60 found in the substancereference record 42 and, if subject information is provided, furthercheck against more conservative limits specific to subject information62. For example where the weight of the subject is known and substancereference record contains limits that are weight specific, the subject'sweight may be used to determine if a more specific limit should beapplied to the infusion parameters. Age can also be used as a subjectspecific characteristic that can activate more conservative limits ifthe drug reference record contains such limit definitions.

The SIG infusion system may also check the expected volume to bedelivered during the infusion will not violate the maximum dose amountper course of treatment. If the addition of the expected volume to bedelivered will exceed maximum dose amount per course of treatment 63,the operator, after satisfying access code requirements, is given theopportunity to override 64 the limit check violation. If the operatoroverrides the limit check violation, the override event is logged to thehistory file 66 and the infusion is save to a database 67. If theoperator does not override the limit check violation 65, the programmedinfusion parameter in violation must be modified to be within limits orthe controller will prevent the infusion from being started.

If the infusion is not associated with a substance reference record 42,then no checking for substance reference record 42 related limits isperformed and the infusion protocol is saved 67 into the appropriatedatabase 22, 24, 26.

Save Created Rx to a Database

After programming all infusion parameters and checking the parametersagainst limits found in the associated substance reference record 42,the infusion is saved to the appropriate database 22, 24, 26. In oneembodiment, if the infusion protocol does not include any substancespecification or subject specification, it is saved 67 to the infusionprotocol database 26 under the therapy specific folder 34 (IVIG, SQIG,or CONT). If the infusion protocol does not contain subject informationbut does contain a substance specification, whether or not thatsubstance specification is found in the substance reference library 40,the infusion is saved 67 to the substance protocol database 22 under thetherapy specific folder 38 (IVIG, SQIG, or CONT). If the infusionprotocol contains subject information then that infusion protocol,including the subject information, is saved 67 to the subject protocoldatabase 24 in that subject's folder 48.

Infusion Configuration Personal Computer Program

The Infusion Configuration Program (ICP) is a program, operable on apersonal computer 28 a that simulates programming of infusion protocolsdirectly on the SIG infusion system 10 a. The ICP creates subjectprotocols, substance protocols or non-specific infusion protocols whichcan be transferred to the appropriate database 22, 24, 26 of the SIGinfusion system 10 a via any of the above mentioned connectivity mediums28 a-28 e.

Selecting an Existing Infusion Protocol from a Database

FIG. 5 illustrates the selection of an infusion protocol from thesubject, substance, and infusion databases 22, 24, 26.

Selecting a Subject-Specific Infusion Protocol

In order to select an existing subject infusion protocol from a subjectprotocol database 24 for infusion, the operator must satisfy the SIGinfusion system's security requirements 70. In one embodiment, theoperator may need to enter an access code on the SIG infusion system viatouch screen entry to satisfy security access. Alternatively, theoperator might be required to identify herself to the SIG infusionsystem program by use of a barcode reader 28 c to read the operator'sbarcode information from a badge, identification card or the like.

In one embodiment, the operator is presented with a selection list 71whereby the operator may select the substance protocol database 22,subject protocol database 24 or infusion protocol database 26. If theoperator selects the subject database, she is presented with a list ofsubjects (e.g., subjects or clinical study participants) from which theoperator must select 72. After the operator selects a particular subject72, if there is more than one subject-specific infusion protocolavailable for that subject 75, a list of available infusion protocolswill be displayed for selection 76. Following the selection of thedesired infusion protocol for that subject, the operator is presentedwith a summary of the infusion protocol 83 which the operator may electto accept, modify, or cancel.

If the operator chooses to modify the selected infusion protocol, she ispresented with the infusion programming screen and may make desiredmodifications 85. After making modifications, the operator accepts themodification and the subject-specific infusion protocol is checkedagainst infusion limits for that substance that may be contained in thesubstance reference library 40. If there is a substance reference record42 for that substance and the infusion parameters do not violate thelimits set in that substance reference record 42, the operator can thensave the modified subject-specific infusion protocol by overwriting theoriginal 87. Alternatively, the operator may elect to save the modifiedsubject-specific infusion protocol saved under a new subject namewithout modifying the original source protocol in the database.

Selecting a Substance Infusion Protocol

In order to select an existing substance infusion protocol from thesubstance protocol database 22 for infusion, the operator must satisfythe SIG infusion system's security requirements 70. In one embodiment,in order to select an existing substance-specific infusion protocol, theoperator may need to enter an access code on the SIG infusion system viatouch screen entry to satisfy security access. Alternatively, theoperator might be required to identify herself to the SIG infusionsystem program by use of a barcode reader 28 c which is used to read theoperator's barcode from the operators badge, identification card or thelike.

In one embodiment the operator is presented with a selection listcontaining selectable databases 71, such as the substance protocoldatabase, subject protocol database and therapy-type protocol database.If the operator selects the substance protocol database, she ispresented with a list of therapeutic types 73: IVIG, SQIG, or CONT. Ifthe operator selects IVIG, she is presented a list of IVIG substanceprotocol records from the substance protocol database 77. If theoperator selects SQIG, she is presented a list of SQIG substanceprotocols from the substance protocol database 78. If the operatorselects CONT, she is presented a list of CONT substance protocols fromthe substance protocol database 78. After selecting a substance-specificinfusion protocol, the operator is presented with a summary of thesubstance-specific infusion protocol parameters 83 to which the operatormay accept, modify, or cancel.

If the operator chooses to modify the selected protocol 84, she ispresented with the infusion programming screen and may make desiredmodifications 85. After making modifications, the operator accepts themodification and, if the substance-specific infusion protocol includes areference to an existing substance reference record 42, the infusion ischecked against substance reference record 42 infusion limits 86. Theoperator can then save the modified infusion as a new substance protocol89 or overwrite the original 87.

If the operator accepts the originally selected substance protocol oraccepts and saves a modified substance protocol, the substance protocolis loaded into the SIG infusion system for infusion.

Selecting an Infusion Protocol Based on Therapy Type

In some embodiments, the system includes a therapy-type infusionprotocol database 26. In order to select an existing therapy-typeinfusion protocol from the therapy-type infusion protocol database 26,the operator must satisfy the SIG infusion system's securityrequirements 70. In one embodiment, in order to select an existingprotocol from the therapy-type infusion protocol database, the operatormay need to enter an access code on the SIG infusion system via touchscreen entry to satisfy security access. Alternatively, the operatormight be required to identify herself to the SIG infusion system programby using a barcode reader 28 c to read a barcode on the operator'sbadge, identification card or the like.

After gaining access to the system, the operator is presented with aselection list of some or all of the available databases. For example,the operator may view a screen that allows the operator to select eitherthe substance protocol database 22, subject protocol database 24 ortherapy-type protocol database. If the operator selects the therapy-typeprotocol database 26, she is then presented with a list of therapeutictypes 74, such as: IVIG, SQIG, or CONT. If the operator selects IVIG,she is then presented a list of one or more IVIG infusion protocol(s)which are suitable for, or have been historically used for, IVIG therapybut which are not specific to any particular substance or any particularsubject. If the operator selects SQIG, she is then presented a list ofone ore more SQIG infusion protocol(s) which are suitable for, or havebeen historically used for, SQIG therapy but which are not specific toany particular substance or any particular subject. If the operatorselects CONT, she is presented a list of one or more CONT infusionprotocols which are suitable for, or have been historically used for,CONT therapy but which are not specific to any particular substance orany particular subject. After selecting a therapy-type infusionprotocol, the controller may then present the operator with a summary ofthe infusion parameters 83, some or all of which may then be accepted,modified or cancelled by the operator.

If the operator chooses to modify the selected infusion protocol 84, sheis presented with the infusion programming touch screen presentationthat may be used by the operator to make the desired modifications 85.After making modifications, the operator can then save the modifiedinfusion protocol as a new therapy-type infusion protocol 89 oroverwrite the original therapy-type infusion protocol that had beenmodified.

If the operator accepts the originally selected therapy-type infusionprotocol, or if the operator accepts and saves a modified therapy-typeinfusion protocol, the controller will then load the selected protocolinto the SIG infusion system 10 a for infusion.

Standby Menu

After a particular infusion protocol has been accepted by the operatorfor infusion or if the operator stops an infusion that is in progress,the operator is presented with a “standby” menu (FIG. 8) allowing her to“run”, “prime”, and “review/modify Rx”. In the event that the operatorstopped an infusion in progress, a “status” selection is provided toallow review of the progress of the now stopped infusion.

Run

Selecting run displays a confirmation run menu asking if it is proper tostart the infusion. Selecting yes to the confirmation menu will causethe infusion to begin running. The SIG infusion system then startspumping and administers the substance according to the loaded Rxinfusion parameters.

Prime

The prime feature allows the operator to prime the administration setwith fluid, replacing any air that may be in the administration set.Selecting prime displays a prime advisory menu instructing the operatorto disconnect the SIG infusion system from the subject. After theoperator responds to the prime advisory menu, the prime screen isdisplayed instructing the operator to press and hold the prime button toprime the administration set. Pressing and holding the prime button willcause up to three milliliters, for example, of fluid to prime theadministration set. If the prime button is released or three millilitersof priming has occurred, the priming will stop. Releasing and thenpressing the prime button again will cause the prime to resume and allowup to another three milliliters to be pumped.

Review/Modify Rx

The review/modify Rx feature allows the operator to review the infusionparameters for the Rx that is loaded. In addition, if subjectinformation and/or substance data is associated with the loaded Rx, thenthat data may also be reviewed. If the operator desires, the Rx underreview may be modified if the operator can satisfy the SIG infusionsystem security requirements.

IVIG Infusion Profile

When infusing an IVIG therapy, the IVIG rate profile starts at the baserate and then increases by the rate increment when the step duration haselapsed. This process of increasing the rate by the rate incrementcontinues at the elapse of the step duration until the maximum rate isachieved or the volume to be infused has been delivered. If in the laststep a full rate increment increase would exceed the maximum rate, thefinal rate is the maximum rate only. The transition from one rate toanother is attained by a controlled ramp to ease the physiologicaleffects of the sudden increase of substance delivery to the subject.Once an infusion reaches the maximum rate, the infusion continues at themaximum rate until the volume to be infused has been delivered.

SQIG Infusion Profile

When infusing a SQIG therapy, the SQIG rate of infusion ramps up to theprogrammed rate of infusion in a controlled manner. Once an infusionreaches the programmed rate, the infusion continues at that rate untilthe volume to be infused has been delivered.

CONT Infusion Profile

When infusing a CONT therapy, the CONT rate of infusion ramps up to theprogrammed rate of infusion according to a programmed up ramp timeparameter. Once the up ramp time has elapsed and the rate of infusionreaches the programmed rate, the infusion continues at that rate untilthe remaining volume to be infused has been delivered. After finishingthe delivery of all the volume to be infused, the SIG infusion systemwill run at the programmed KVO rate.

Realtime Display of Infusion Progress

When the infusion begins running, the infusion status screen isdisplayed showing: volume infused, remaining volume to be infused,current rate, target rate, infusion time, and remaining time. For IVIGtherapy, current step is included on the infusion status screen.

Interaction by Operator with an Infusing Rx

While an infusion is running, the operator may interact with theinfusion by stopping (pausing) or titrating the infusion.

Stopping an Infusion

Anytime that an infusion is running, the operator my stop the infusionby pressing a stop button. So doing will cause the infusion to stop anddisplay the standby menu, providing selections of run, prime,review/modify Rx and status.

Titrating

While the SIG infusion system is running an infusion, the operator canchoose to titrate or change the infusion rate by pressing a button onthe infusion status menu. Changing the infusion rate may require theoperator to enter an access code on the SIG infusion system via touchscreen entry to satisfy security access. Alternatively, the operatormight be required to identify herself to the SIG infusion system programby use of a barcode reader, attached to the SIG infusion system, whichis used to read the operator's barcode information from her badge.

If the therapy type is IVIG and therefore has a stepping profile, ascreen is displayed giving the operator the choice of keeping thecurrent stepping profile or finishing the remainder of the infusion atthe new infusion rate. Retaining the stepping profile may cause thenumber of steps in the remainder of the infusion to be recalculated.

Adverse Reaction Monitoring

Adverse reaction monitoring (ARM) monitors the subject's vital signs andsubject's symptom responses to help the operator determine if thesubject is having an adverse reaction to the infusion. In order to useARM, the SIG infusion system must be loaded with a substance protocolfor which a substance reference record 42 exists in the substancereference library 40. Prior to using ARM for vital signs, subject'svital signs data must be taken to establish a baseline reference forsubsequent reading of vital signs.

Vital Signs

Vital signs monitoring is the periodic acquisition of physiologicalvital signs data from a subject. Vital signs to be monitored and thefrequency of monitoring are determined by the institution responsiblefor the infusion and found in the substance reference record 42. Vitalsigns monitored include blood pressure, temperature, pulse rate, oxygensaturation level, etc. Vital signs data may be acquired automatically bythe SIG infusion system if it is connected to automated vital signsmonitoring equipment and the subject is connected to the automated vitalsigns monitors. Where no automated vital signs monitoring equipment isavailable, vital sign data may manually be entered into the SIG infusionsystem. The scheduling of vital sign acquisition and detecting ofadverse reaction based on vital signs data is set by parameters in thesubstance reference record 42 and the programmed protocol.

Subject Symptom

Subject symptom monitoring is the periodic acquisition of subjectsymptoms. Subject symptoms to be monitored and the frequency ofmonitoring are determined by the institution responsible for theinfusion and found in the substance reference record 42. Typical subjectsymptoms monitored include headache, light-headedness, chills, shortnessof breath, nausea or vomiting, etc. When prompted by the SIG infusionsystem, the operator will determine the subject's condition relative tothe symptom being asked by the SIG infusion system. The operator mustmanually enter the subject symptom responses to the SIG infusion system;there is no automatic entry of subject symptoms. The scheduling ofacquisition of subject symptoms and detecting of adverse reaction basedon subject symptom data is set by parameters in the substance referencerecord 42 and programmed protocol.

Detection and Handling of Adverse Reactions

Referring to FIG. 6, if the substance reference record 42 has been setupto require the acquisition of vital signs data 100 and, according tovital signs monitoring schedule, the acquisition of vital signs is duewithin two minutes, then the operator is notified of the approachingscheduled vital signs acquisition by an audible beep and message on thedisplay. When it is time to acquire vital signs 101, a menu is displayed102 to the operator so indicating. This menu 102 includes a selectionthat allows the operator to skip the acquisition of vital signs. If theoperator chooses to skip the acquisition of vital signs 103, she mustenter an access code and an entry is made to the history file indicatingthe acquisition of vital signs was skipped. If the system includesautomated vital signs monitoring equipment connected to the SIG infusionsystem, the SIG infusion system will automatically initiate theacquisition of vital signs data 104; otherwise, the operator is promptedto enter the vital signs data 104 on the SIG infusion system manually.If the substance reference record 42 has not been setup to require theacquisition of vital data then no prompt or attempt to acquire vitalsigns is made. If the substance reference record 42 has been setup torequire vital sign data be acquire but, according to vital signsmonitoring schedule, it is not time to acquire vital signs, no prompt orattempt to acquire vital signs is made.

If the substance reference record 42 has been setup to require theacquisition of subject symptom responses 105 and if according to thesubject symptom query monitoring schedule the acquisition of subjectsymptom responses is due in two minutes, the operator is notified of theapproaching scheduled subject symptom response acquisition by an audiblebeep and message on the display. When it is time to acquire subjectsymptom responses 106, a menu is displayed 107 to the operator soindicating. This menu 107 includes a selection that allows the operatorto skip the acquisition of subject symptom responses. If the operatorchooses to skip the acquisition of subject symptom responses 108, shemust enter an access code and an entry is made to the history fileindicating the acquisition of subject symptom responses was skipped. Ifthe operator does not skip the acquisition of subject symptom responses,the operator then manually enters 109 the subject symptom responses asprompted by the menu displayed. If the substance reference record 42 hasnot been setup to require the acquisition of subject symptom responses,then no prompt to acquire subject symptom responses is made. If thesubstance reference record 42 has been setup to require the acquisitionof subject symptom responses but, according to subject symptommonitoring schedule, it is not time to acquire subject symptomresponses, no prompt to acquire subject symptom responses is made.

If vital signs data and/or subject symptom responses had been acquired110, they are analyzed according to the limits and parameters setup inthe substance reference record 42 associated with the infusion 111. Ifno adverse reaction is thereby detected 112, the subject is consideredsufficiently tolerant of the infusion and a designation of “green zone”is used to describe the subject's condition. The SIG infusion systemwill continue to run the infusion while the subject is in a green zonecondition.

If the subject is suffering a mild adverse reaction 114, as determinedby the analysis described above, the infusion stops and the subject'scondition is classified as a “yellow zone” condition 115. For a yellowzone condition, the operator is given the opportunity by the SIGinfusion system to retake or enter the vital sign(s) and/or subjectsymptom(s) 116 related to the reason the mild adverse reaction wasdetected. If the operator retakes and enters the vital sign(s) and/orsubject symptoms(s) 120 the operator is given the opportunity to havethe new data analyzed 119 according to the limits and parameters setupin the substance reference record 42. If the operator chooses to analyzethe new data, processing for detection of adverse reactions starts anew.If the operator chooses not to analyze the new data or if she choosesnot to retake vital sign(s) and/or subject symptom(s), the SIG infusionsystem will suggest a lower infusion rate and allow the operator toaccept the lower suggested rate or enter an even lower rate to be usedwhen the infusion is resumed 117. If the operator chooses to use thesuggested lower rate or a lower rate she had entered, then the new lowerrate is applied 118 and used when the infusion is resumed. If theoperator chooses not to use the suggested lower rate or enter an evenlower rate, then the operator is given the opportunity to override themild adverse reaction advisory 121. If the operator chooses to overridethe mild adverse reaction advisory, she is required to provide an accesscode and her action is recorded to a history file 122. If the operatorchooses not to override the adverse reaction advisory, she is againgiven the opportunity to accept the SIG infusion system suggested lowerinfusion rate or enter an even lower infusion rate.

If the subject is suffering a severe adverse reaction 114, as determinedby the analysis described above, the infusion stops and the subject'scondition is classified as a “red zone” condition 124. For a red zonecondition, the operator is given the opportunity by the SIG infusionsystem to retake and enter the vital sign(s) and/or subject symptom(s)125 related to the reason the severe adverse reaction was detected. Ifthe operator retakes and enters the vital sign(s) and/or subjectsymptom(s) 128 the operator is given the opportunity to have the newdata analyzed 127 according to the limits and parameters setup in thesubstance reference record 42. If the operator chooses to analyze thenew data 127, processing for detection of adverse reactions starts anew.If the operator chooses not to analyze the new data or if she choosesnot to retake vital sign(s) and/or subject symptom(s), the infusion isterminated 126 and cannot be resumed.

History Database

A history files or log is used in the SIG infusion system to recordinfusion activities, malfunctions, alarms, alerts, advisories and eventsthat may occur while the SIG infusion system is turned on. The historyfile records the activities normally associated with setting up andoperating the SIG infusion system. Information such the Infusionprotocol parameters for an infusion, modifications to an Infusionprotocol, occurrences of alerts, alarms and malfunctions, the operatorselecting to override of limits or suggestions made by the SIG infusionsystem, and all activities which required the operator to provide anaccess code to perform. By using an access code, the history file can bereviewed on the SIG infusion system, copied to a personal computer, andprinted. In addition, the history file can be cleared by using anauthorizing access code. However, though the history file appearscleared to normal operators, its contents prior to clearing aremaintained by the SIG infusion system and may be reviewed and retrievedby factory personnel via factory access code.

It is to be appreciated that the invention has been described hereabovewith reference to certain examples or embodiments of the invention butthat various additions, deletions, alterations and modifications may bemade to those examples and embodiments without departing from theintended spirit and scope of the invention. For example, any element orattribute of one embodiment or example may be incorporated into or usedwith another embodiment or example, unless to do so would render theembodiment or example unsuitable for its intended use. Also, where thesteps of a method or process are described, listed or claimed in aparticular order, such steps may be performed in any other order unlessto do so would render the embodiment or example un-novel, obvious to aperson of ordinary skill in the relevant art or unsuitable for itsintended use. All reasonable additions, deletions, modifications andalterations are to be considered equivalents of the described examplesand embodiments and are to be included within the scope of the followingclaims.

1.-115. (canceled)
 117. A method for programming a controller thatcontrols the infusion of an infusate, said method comprising the stepsof: A) defining a total volume of infusate to be infused or the totalamount of a substance contained in the infusate to be deliveredparameter; B) defining an initial rate parameter; C) defining a maximumrate parameter; D) defining a minimum duration parameter; E) defining amaximum duration parameter; F) defining an incremental step rateparameter; and G) defining an incremental step duration parameter. 118.A method according to claim 117 wherein defining of parameters isaccomplished by an operator manually entering information to thecontroller.
 119. A method according to claim 117 wherein the devicefurther comprises a reader apparatus and wherein said parameters aredefined in Steps A-G by using the reader apparatus to read a barcode orother machine readable code.
 120. A method according to claim 117wherein the device further comprises a memory device that is connectedor connectable to the controller and wherein said parameters are definedin Steps A-G by copying information contained in the memory device. 121.A method according to claim 117 wherein the device further comprises acomputer that is connected or connectable to the controller and whereinsaid parameters are defined in Steps A-G by copying informationcontained in the computer.
 122. A method according to claim 121 whereinthe device further comprises a remotely located computer thatcommunicates with the controller through a wired or wireless connectionand wherein the parameters are defined in Steps A-G by a remote operatorwho enters the parameters on the remote computer. wherein the substancedelivered in Step C comprises at least one blood component for treatmentof an autoimmune disease. 122.-132. (canceled)